
Alfa Wassermann Diagnostic Technologies, Inc.
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S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST is an FDA 510(k)-cleared medical device (K072142) manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2008. Regulation: 8.